MK-6194 for Vitiligo

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Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Merck Sharp & Dohme LLC
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MK-6194 for individuals with non-segmental vitiligo, a condition that causes skin to lose its color in patches. Researchers aim to determine if MK-6194 is safe, well-tolerated, and effective at reducing vitiligo patches on the face compared to a placebo. Participants will receive either MK-6194 or a placebo in varying dosages. Individuals with non-segmental vitiligo who have had the condition for at least six months and have noticeable face patches may be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain prohibited medications within specific timeframes before joining the study, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that MK-6194 is likely to be safe for humans?

Research has shown that MK-6194, a new treatment being tested for non-segmental vitiligo, has some safety data from earlier studies. MK-6194 is a modified version of interleukin-2, designed to activate certain immune cells that help control the immune system.

In previous studies, this treatment was used in people, and the safety results were promising. Most patients tolerated the treatment well. Some side effects occurred, but they were generally mild. This suggests that MK-6194 is unlikely to cause serious side effects for most patients.

This trial is in its middle phase, which aims to further assess the safety and tolerance of MK-6194. This phase is crucial for understanding the treatment's safety. While more information is needed, current results offer reassurance about the treatment's safety for those considering joining the study.12345

Why do researchers think this study treatment might be promising for vitiligo?

Researchers are excited about MK-6194 for vitiligo because it offers a new approach compared to current treatments like corticosteroids and phototherapy. Unlike these standard methods, which often work by suppressing the immune system or using light therapy to achieve repigmentation, MK-6194 is designed to target specific pathways involved in skin pigmentation. This targeted action could potentially lead to more precise and effective results with fewer side effects. Additionally, MK-6194 is administered subcutaneously, which might offer a more convenient and consistent delivery compared to topical treatments.

What evidence suggests that MK-6194 might be an effective treatment for vitiligo?

Research has shown that MK-6194 may help treat non-segmental vitiligo. One study involved 12 patients with difficult-to-treat vitiligo using MK-6194, and 7 of them saw their skin color improve by about 51.4%. This suggests that MK-6194 might help restore skin color in people with vitiligo. In the current trial, participants will receive either MK-6194 or a placebo to compare their effects, using a special index to evaluate MK-6194's effectiveness. These early results offer promise for those seeking new vitiligo treatments.12678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for individuals with non-segmental vitiligo, which causes loss of skin color in blotches. Participants must have had the condition for at least 6 months and show a certain amount of facial and body depigmentation. Those with hands and feet involvement or other forms of vitiligo are not eligible.

Inclusion Criteria

You have a Total Vitiligo Area Scoring Index (T-VASI) of at least 4 at the time of screening and baseline.
I have widespread vitiligo for more than 6 months.
You have a BSA of at least 0.3% on your face with no pigmentation present.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous MK-6194 or placebo for up to 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may opt into continuation of treatment with MK-6194 regimen 1 or 2

What Are the Treatments Tested in This Trial?

Interventions

  • MK-6194
Trial Overview The study tests MK-6194 against a placebo to see if it's better at improving the appearance of vitiligo on the face after 24 weeks. The main goal is to check how much this treatment can change the extent of skin color loss compared to no active treatment.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Extension: Dose 2Experimental Treatment2 Interventions
Group II: Extension: Dose 1Experimental Treatment1 Intervention
Group III: Base Study: Dose 2Experimental Treatment2 Interventions
Group IV: Base Study: Dose 1Experimental Treatment1 Intervention
Group V: Base Study: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

Emerging Therapeutic for Non-Segmental Vitiligo: Merck's ...Iltefat Hamzavi, MD, discusses the REGINA 007 phase 2 trial evaluating MK-6194 for the treatment of non-segmental vitiligo.
Up-and-Coming Drugs for the Treatment of Vitiligo - PMCIn 12 patients with recalcitrant vitiligo, 7 patients presented an average improvement in pigmentation of 51.4% without relevance to age, sex, disease duration, ...
Clinical study of MK-6194 in adults with non-segmental ...The main objective of this study is to examine the efficacy of MK-6194, compared to the placebo, using a vitiligo point index. This is used to determine the ...
Study on MK-6194 for Treating Adults with Non-Segmental ...This study investigates the efficacy and safety of MK-6194, an injectable treatment under test for adults with non-segmental vitiligo, a skin condition ...
Clinical TrialsThis Phase 2a, multicenter, randomized, double-blind, placebo-controlled study evaluates the safety and efficacy of MK-6194 in adult participants with non- ...
MK-6194 / Merck (MSD) - Dermatology • ImmunologyFirst-in-human safety, pharmacokinetics, and pharmacodynamics data with MK-6194, a modified form of interleukin-2, designed to selectively activate regulatory ...
A Clinical Study of MK-6194 for the Treatment of Vitiligo ...The purpose of this study is to evaluate the efficacy, safety, and tolerability of MK-6194 in participants with non-segmental vitiligo. The ...
A Clinical Study of MK-6194 for the Treatment of Vitiligo - MSDThe goal of this study is to learn about the safety of MK-6194 and how well people tolerate it. Researchers also want to learn if people who take MK-6194 ...
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